Settlement Reached in Fosamax Dead Jaw Syndrome Lawsuit

A confidential settlement on damages has been reported in a Fosamax lawsuit brought by the estate of a Florida woman who developed Osteonecrosis of the Jaw (ON J or Dead Jaw Syndrome) while taking the bisphosphonate drug. According to a report from Law360.com, the woman’s estate had originally been awarded $8 million by a jury, but the federal judge presiding over it and hundreds of other Fosamax Dead Jaw Syndrome lawsuits had reduced that to $1.5 million.

According to the lawsuit, Shirley Boles had been prescribed Fosamax because of a stress fracture in her foot. She eventually developed problems in her mouth and then ONJ. Her lawsuit was the first bellwether case to go to trial in the federal Fosamax litigation currently underway in federal court in New York. The jury hearing the case found in Boles’ favor in June 2010, awarding her $3 million more in compensatory damages than the $5 million her lawsuit sought. However, in October 2010, U.S. District Judge John F. Keenan found that the award was “unreasonably high,” and reduced it to $1.5 million, giving the plaintiff the option of having the case retried. At the time, Merck said it would appeal Keenan’s refusal to throw out the verdict entirely or to order a new trial.

Fosamax and other oral bisphosphonates, including Boniva and Actonel, are approved to treat bone weakening diseases like osteoporosis and Paget’s disease. In 2005, the U.S. Food & Drug Administration (FDA) ordered that warnings about ONJ be added to labels for Fosamax and other bisphosphonates. It is believed that Osteonecrosis may develop when bisphosphonates prevent the body from repairing microscopic damage to the jawbone, such as what is seen during routine dental procedures.

Bisphosphonates like Fosamax have been associated with a number of other serious side effects. In October 2010, for example, the FDA asked the manufacturers of bisphosphonates used to treat osteoporosis, including Fosamax and Boniva, to add information to the “Warnings and Precautions” section of the drugs’ labels describing the risk of atypical thigh fractures after a study linked long-term use of such drugs to this side effect. Most recently, studies have indicated that long-term use of oral bisphosphonates may increase risks for esophageal cancer.

Earlier this year, the FDA published data suggesting that there may be no benefit to taking Fosamax and its sister drugs on a long-term basis. After reviewing data from 2,342 women, the agency stated that there is “little benefit of continued bisphosphonate treatment beyond 5 years.” Another recent study, published in the Archives of Internal Medicine, found that 82 percent of patients with atypical femur fractures had been taking bisphosphonates.